Xarelto is under fire, if you follow the allegations in the over 550 lawsuits filed to date. Xarelto is one of the newer oral anticoagulant medications that has been approved by the FDA. The federal Xarelto personal injury and product liability claims are centralized before U.S. District Judge Eldon E. Fallon in the Eastern District of Louisiana.
Bayer and Johnson & Johnson (J&J) as co-developers, are exposed to at least 552 bleeding cases in the federal multi-district litigation (MDL), according to a Docket Report issued by the U.S. Judicial Panel on Multidistrict Litigation, with thousands more on the way.
U.S. District Judge Fallon presiding over all federal Xarelto bleeding lawsuits has indicated a series of bellwether trials in the federal multidistrict litigation (MDL) may begin by August 2016.
Judge Fallon has indicated that a small group of “bellwether” cases will be selected for early trial dates. Accordingly, it has been proposed that fifty plaintiffs be selected for a “pool” of bellwether cases, which will go through case-specific discovery in preparation for a series of trials in 2016.
According to experts, the final tally may exceed several thousands before the litigation is settled. The plaintiffs blame the manufacturers for the severe, and often fatal bleeding injuries that were caused by Xarelto side effects.
Xarelto Lack of Adequate Warnings
Plaintiffs allege that the drug makers neglected to adequately warn about the risks associated with the new-generation anticoagulant and the lack of an effective antidote for Xarelto, in the event of uncontrollable bleeding.
Xarelto Uncontrollable Bleeding Risks
Xarelto (rivaroxoaban) is a new-generation anticoagulant approved by the FDA in 2011 as a replacement for Coumadin (warfarin). Coumadin, has been the “gold standard” medication for prevention of blood clots and strokes in patients with atrial fibrillation, a common heart rhythm abnormality for the past 60 years.
All blood thinners carry a risk of bleeding, BUT Xarelto has been linked to a severe injuries as more patients are transferred over to the new blood thinner.
Xarelto has been touted as a safer alternative to Coumadin, with the drug makers promoting that it is easier to use, since it does not require regular blood tests to measure its effectiveness.
According to several recent studies there are concerns about those claims, with researchers noting that Xarelto blood tests may help doctors identify patients at the greatest risk of bleeding. Additionally, plaintiffs blame the drug makers for withholding critical information about the lack of a Xarelto reversal agent, which doctors could use to stop uncontrollable hemorrhaging.
Coumadin’s blood thinning effects can be quickly reversed in an emergency, there is no similar antidote for Xarelto.
Xarelto is a $Billion Dollar Blockbuster Drug
According to court documents, Xarelto has raked in over $2 billion in sales nationwide with over one million prescriptions written by 2013, two years after the drug’s introduction into the market. Xarelto is a huge cash cow for the pharma division at J&J.
Xarelto, has grabbed a 32 percent market share in the highly competitive anticoagulant market, significantly ahead of Boehringer’s Pradaxa and Bristol-Myers Squibb’s Eliquis, the other two new anticoagulants in the market. The Xarelto pony is way ahead in the three way pony race.
Company sales representatives continued to tout Xarelto as a convenient alternative to the established blood-thinner warfarin, but by the end of 2012, there had been 2,080 Xarelto-related injuries, including 151 deaths.
Xarelto Federal MDL Lawsuits
The MDL has an important role in streamlining the litigation process, as all plaintiffs and defendants are under one roof, coordinate discovery and the bellwether trials can be set to determine the strength of the claims.
As part of the coordinated pretrial proceedings, it is common in complex pharmaceutical and medical device mass tort litigation, that a small group of cases will be selected as “bellwether” cases.
These lawsuits will be prepared for early trial dates to help the parties determine how juries may respond to certain evidence and similar testimony that is likely to be repeated throughout the litigation.
Pradaxa, which is another new-generation anticoagulant introduced by Boehringer Ingelheim in October 2010, one year before Xarelto hit the market. More than 4,000 Pradaxa lawsuits were filed by users of that drug who suffered bleeding injuries. Boehringer Ingelheim ultimately agreed to pay $650 million in Pradaxa settlements, with an average of about $150,000 per claim.
Xarelto State Court Actions
There are several hundred more cases pending in various state courts nationwide, including about 170 pending in Pennsylvania state court, where a Xarelto mass tort was established in January.